Bimatoprost
Other / unclassified targets PTGFR via activation
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed glaucoma 1, open angle, P 1 milestone | |||||
| Filed | US (FDA) | — | glaucoma 1, open angle, P | 2019-07-17 | “today announced that the U.S. Food and Drug Administration ( FDA ) has accepted the company's New Drug Application (NDA) for Bimatoprost Sustained-Release (SR).” abbvie.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansion | US (FDA) | LATISSE | — | 2014-09-04 | fda.gov ↗ |
| Label expansion | US (FDA) | LUMIGAN | — | 2006-06-22 | fda.gov ↗ |
| Approved | EU (EMA) | Lumigan | — | 2002-03-08 | europa.eu ↗ |
| Approved | US (FDA) | LUMIGAN | — | 2001-03-16 | fda.gov ↗ |
Trials 101 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT04738149 | Nov 2021 → May 2022 | vitiligo | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 0 | NCT03708627 | Nov 2017 → Jul 2029 expected | disease of orbital part of eye adnexa | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 0 | NCT02830776 | Nov 2016 → Apr 2017 | eyelid disorder | Tulane University | Completed | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT07641296 | Jul 2026 → Feb 2027 expected | glaucoma, ocular hypertension | SpyGlass Pharma, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05729594 | Feb → Apr 2023 | — | Laboratoires Thea | Completed | No outcome recorded |
| Phase 1 | NCT02848300 | Jul → Oct 2016 | androgenetic alopecia | Allergan | Completed | No outcome recorded |
| Phase 1 | NCT02676310 | Mar 2016 → Jan 2017 | androgenetic alopecia | Allergan | Terminated | No outcome recorded |
| Phase 1 | NCT02444767 | Mar → Apr 2015 | — | ForSight Vision5, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01189279 | Oct 2010 → Jan 2011 | baldness, male pattern | Allergan | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06120842 | Oct 2023 → Jan 2025 overdue | cataract, glaucoma, ocular hypertension | SpyGlass Pharma, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05600673 | Jan 2019 → Jan 2021 | alopecia areata | Ahmed Hassan Nouh MD | Completed | No outcome recorded |
| Phase 1/2 | NCT02742649 | Apr → Dec 2016 | ocular hypertension, open-angle glaucoma | ForSight Vision5, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT01157364 | Sep 2010 → Jul 2016 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
| Phase 216 trials | ||||||
| Phase 2 | NCT06122090 | Jul 2023 → Dec 2024 | hypopigmentation of the skin, reactive cutaneous fibrous lesion | Medstar Health Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT04747808 | Jan → Feb 2021 | ocular hypertension, open-angle glaucoma | MediPrint Ophthalmics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03419715 | Jan 2018 → Apr 2019 | migraine disorder | Manistee Partners | Unknown | No outcome recorded |
| Phase 2 | NCT03292796 | Dec 2016 → Oct 2019 | open-angle glaucoma | Julie Dawson | Completed | No outcome recorded |
| Phase 2 | NCT02537015 | Aug 2015 → Aug 2016 | ocular hypertension, open-angle glaucoma | ForSight Vision5, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02358369 | Jan → Aug 2015 | ocular hypertension, open-angle glaucoma | ForSight Vision5, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02143843 | Jun 2014 → Dec 2015 | ocular hypertension, open-angle glaucoma | ForSight Vision5, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01915940 | Oct 2013 → Sep 2014 | ocular hypertension, open-angle glaucoma | ForSight Vision5, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01904721 | Aug 2013 → Sep 2014 | androgenetic alopecia | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT01325350 | Jun 2011 → Jul 2012 | androgenetic alopecia | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT01325337 | Jun 2011 → Aug 2012 | baldness, male pattern | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT01291108 | Apr → Oct 2011 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT01064882 | Mar → Jul 2010 | hypotrichosis of eyelid | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT00538304 | Nov 2007 → May 2008 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT00652496 | Jan → May 2005 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT00651859 | Nov 2002 → Jan 2004 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00300443 | Dec 2005 → Jun 2007 | ocular hypertension | Allergan | Completed | Mixed |
| Phase 331 trials · 7 met primary | ||||||
| Phase 3 | NCT07218796 | Oct 2025 → May 2029 expected | cataract, glaucoma, ocular hypertension | SpyGlass Pharma, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07218783 | Oct 2025 → Mar 2029 expected | cataract, ocular hypertension, open-angle glaucoma | SpyGlass Pharma, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05397600 | Jun 2022 → Mar 2024 | glaucoma, ocular hypertension | Laboratoires Thea | Completed | No outcome recorded |
| Phase 3 | NCT04898387 | Mar 2021 → Apr 2023 | ocular hypertension | Laboratoires Thea | Completed | No outcome recorded |
| Phase 3 | NCT04285580 | Jun 2020 → May 2022 | ocular hypertension, open-angle glaucoma | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03891446 | Mar 2019 → Jun 2026 | ocular hypertension, open-angle glaucoma | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03850782 | Feb 2019 → Aug 2025 | ocular hypertension, open-angle glaucoma | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03825380 | Nov 2018 → Feb 2021 | glaucoma, ocular hypertension | Laboratoires Thea | Completed | No outcome recorded |
| Phase 3 | NCT02636946 | Feb 2016 → Jan 2021 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT02390284 | Sep 2015 → Oct 2024 | glaucoma | University of Miami | Terminated | No outcome recorded |
| Phase 3 | NCT02507687 | Aug 2015 → Nov 2021 | ocular hypertension, open-angle glaucoma | AbbVie | Completed | Met primary |
| Phase 3 | NCT02250651 | Dec 2014 → Oct 2018 | ocular hypertension, open-angle glaucoma | Allergan | Completed | Met primary |
| Phase 3 | NCT02155049 | Nov 2014 → May 2017 | disease of orbital part of eye adnexa | Rabin Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01830140 | Jul 2013 → May 2014 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT01765764 | Mar 2013 → Jan 2014 | hypotrichosis | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT01698554 | Nov 2012 → Feb 2014 | hypotrichosis of eyelid | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT01426113 | Sep 2011 → Oct 2014 | glaucoma | Allergan | Terminated | No outcome recorded |
| Phase 3 | NCT01391273 | Jul 2011 → May 2012 | hypotrichosis of eyelid | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT01391286 | Jul 2011 → May 2012 | hypotrichosis of eyelid | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT01241240 | Mar 2011 → Sep 2013 | ocular hypertension, open-angle glaucoma | Allergan | Completed | Met primary |
| Phase 3 | NCT01217606 | Jan 2011 → Sep 2014 | ocular hypertension, open-angle glaucoma | Allergan | Completed | Met primary |
| Phase 3 | NCT01216943 | Nov 2010 → Aug 2012 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT01168414 | Aug 2010 → Jan 2011 | ocular hypertension, open-angle glaucoma | Ministry of Health, Malaysia | Completed | No outcome recorded |
| Phase 3 | NCT01099774 | May 2010 → Apr 2011 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT00907426 | Aug 2009 → Nov 2010 | hypotrichosis | Allergan | Completed | Met primary |
| Phase 3 | NCT00693420 | Apr → Oct 2007 | — | Allergan | Completed | Met primary |
| Phase 3 | NCT01200251 | Feb → Sep 2007 | alopecia, isolated, hypotrichosis | Duke University | Completed | No outcome recorded |
| Phase 3 | NCT00332059 | May 2003 → Sep 2004 | ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT00332072 | Aug 2001 → Aug 2003 | ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT00332540 | Aug 2001 → Aug 2003 | ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT02154217 | ? → Dec 2004 | glaucoma | University of Milan | Completed | Met primary |
| Phase 436 trials · 4 met primary | ||||||
| Phase 4 | NCT07845357 | Oct 2026 → Feb 2027 expected | dry eye syndrome, glaucoma | Southern College of Optometry | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07217678 | Feb 2026 → Jan 2028 expected | borderline glaucoma, ocular hypertension, open-angle glaucoma | University of Miami | Recruiting | No outcome recorded |
| Phase 4 | NCT04981886 | Aug 2021 → Jul 2022 | low tension glaucoma | Salus University | Unknown | No outcome recorded |
| Phase 4 | NCT06761313 | Mar 2021 → Dec 2024 overdue | glaucoma | Federal University of São Paulo | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03487042 | May 2018 → Dec 2019 | generalized vitiligo | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT02863705 | Jul 2016 → Jul 2018 | low tension glaucoma | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT02571712 | Nov 2015 → Jun 2018 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT02471105 | Sep 2015 → May 2017 | glaucoma, ocular hypertension | Universitaire Ziekenhuizen KU Leuven | Unknown | Met primary |
| Phase 4 | NCT02176356 | Jun 2014 → May 2015 | — | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01927406 | Jun 2014 → Dec 2016 | endocrine exophthalmos, glaucoma, ocular hypertension | Stanford University | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03966560 | Jan 2014 → Jan 2015 | open-angle glaucoma | Afyon Kocatepe University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01975714 | Oct 2013 → Feb 2015 | glaucoma, ocular hypertension | Association for Innovation and Biomedical Research on Light and Image | Completed | No outcome recorded |
| Phase 4 | NCT01891487 | May 2013 → Sep 2014 | hypotrichosis | ATS Clinical Research | Completed | No outcome recorded |
| Phase 4 | NCT01594970 | Mar 2012 → Jan 2013 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01535768 | Feb 2012 → Jun 2018 | glaucoma | Credit Valley EyeCare | Unknown | No outcome recorded |
| Phase 4 | NCT01978015 | Oct 2011 → Jul 2012 | anterior uveitis, cystoid macular edema | University of Campinas, Brazil | Completed | No outcome recorded |
| Phase 4 | NCT01464424 | Oct 2011 → Jun 2012 | ocular hypertension, open-angle glaucoma | Alcon Research | Completed | Met primary |
| Phase 4 | NCT02020512 | Jul 2011 → Dec 2012 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01298700 | May 2011 → Dec 2016 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01387906 | Mar 2011 → Mar 2012 | hypotrichosis | Kenneth Beer | Completed | No outcome recorded |
| Phase 4 | NCT01271686 | Jan 2011 → Oct 2012 | glaucoma, ocular hypertension | University of California, San Diego | Completed | Met primary |
| Phase 4 | NCT01202513 | Aug → Nov 2010 | vitiligo | Gian Sagar Medical College and Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT02061683 | Apr 2010 → Jun 2011 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01833741 | Dec 2009 → Mar 2011 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00958035 | Nov 2009 → Jul 2010 | hypotrichosis | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01229423 | Nov 2009 → Jun 2010 | hypotrichosis of eyelid | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00941096 | Jul 2009 → Nov 2010 | glaucoma, ocular hypertension | Larissa University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00539526 | Sep 2007 → Jul 2008 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00440011 | Aug 2006 → Oct 2007 | glaucoma, ocular hypertension | Allergan | Completed | Met primary |
| Phase 4 | NCT00273455 | Jan 2006 → May 2007 | open-angle glaucoma | Pharmaceutical Research Network | Completed | No outcome recorded |
| Phase 4 | NCT00329095 | Dec 2005 → Apr 2006 | glaucoma, ocular hypertension | Robin, Alan L., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT00355446 | Jul 2001 → Oct 2004 | cataract | Indiana University | Completed | No outcome recorded |
| Phase 4 | NCT00348062 | — | glaucoma | Innovative Medical | Completed | No outcome recorded |
| Phase 4 | NCT00347802 | — | glaucoma | Innovative Medical | Completed | No outcome recorded |
| Phase 4 | NCT00347841 | — | glaucoma | Innovative Medical | Completed | No outcome recorded |
| Phase 4 | NCT00348023 | — | glaucoma | Innovative Medical | Completed | No outcome recorded |
| Phase not applicable4 trials · 1 met primary · 1 missed | ||||||
| — | NCT07154797 | Apr → Dec 2022 | cataract, glaucoma, ocular hypertension | SpyGlass Pharma, Inc. | Completed | Met primary |
| — | NCT00999557 | Jan 2016 → Aug 2017 | alopecia, breast cancer | Jonsson Comprehensive Cancer Center | Withdrawn | No outcome recorded |
| — | NCT02448043 | Jun 2015 → May 2016 | ocular hypertension | Northwestern University | Completed | Missed primary |
| — | NCT01361841 | Jan 2009 → Jan 2012 | ocular hypertension, open-angle glaucoma | Centre de recherche du Centre hospitalier universitaire de Sherbrooke | Unknown | No outcome recorded |
| Comparator or background therapy39 trials | ||||||
| Phase 1/2 | NCT00809848 Comparator | Feb → May 2009 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT05335122 Comparator | Mar 2022 → Jan 2024 | ocular hypertension, open-angle glaucoma | Ocular Therapeutix, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01863953 Comparator | Jun → Dec 2013 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT01110499 Comparator | Jun 2010 → May 2011 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT01001195 Comparator | Nov 2009 → Apr 2010 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT02170662 Comparator | Nov 2009 → May 2011 | baldness, male pattern | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT01016691 Background | Oct 2009 → Feb 2010 | ocular hypertension, open-angle glaucoma | Vistakon Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT07661329 Comparator | Jun 2026 → Nov 2027 expected | ocular hypertension, open-angle glaucoma | YS Life Science Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT03927443 Comparator | Jun → Jul 2019 | ocular hypertension, open-angle glaucoma | Sun Pharmaceutical Industries, Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT03284853 Comparator | Sep 2017 → Nov 2020 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01177098 Comparator | Oct 2010 → Feb 2012 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT06369077 Comparator | Apr → Jul 2024 | open-angle glaucoma | CT Glaucoma Associates | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02419508 Background | Aug 2015 → Feb 2018 | ocular hypertension, open-angle glaucoma | Alcon Research | Completed | Met primary |
| Phase 4 | NCT02059655 Comparator | Nov 2014 → Mar 2016 | disease of orbital part of eye adnexa | Cardiff University | Completed | No outcome recorded |
| Phase 4 | NCT02097719 Comparator | May → Dec 2014 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT02017327 Comparator | Dec 2013 → Jul 2016 | ocular hypertension, open-angle glaucoma | Laboratoires Thea | Completed | No outcome recorded |
| Phase 4 | NCT01937312 Background | Oct 2013 → May 2014 | ocular hypertension, open-angle glaucoma | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01881126 Comparator | Jun 2013 → Oct 2014 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01664039 Comparator | Sep 2012 → Jun 2014 | glaucoma, ocular hypertension | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01525173 Comparator | Jan → Oct 2012 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01547598 Comparator | Dec 2011 → Jul 2013 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01448525 Comparator | Oct 2011 → Apr 2012 | hypotrichosis | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01263444 Background | Mar 2011 → Apr 2013 | glaucoma, ocular hypertension | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01253902 Comparator | Dec 2010 → Oct 2011 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01243567 Comparator | Jun 2010 → Feb 2012 | open-angle glaucoma | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01023841 Comparator | Jun 2010 → Nov 2012 | alopecia areata, hypotrichosis of eyelid | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01448837 Comparator | Apr 2010 → Mar 2011 | glaucoma | Aristotle University Of Thessaloniki | Completed | No outcome recorded |
| Phase 4 | NCT01170884 Comparator | Dec 2009 → Sep 2010 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00705757 Comparator | Mar 2008 → Apr 2011 | glaucoma, hyperpigmentation of the skin | Summa Health System | Completed | No outcome recorded |
| Phase 4 | NCT00541242 Comparator | Dec 2007 → Aug 2008 | glaucoma, ocular hypertension | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00847483 Comparator | Jan → Aug 2002 | glaucoma, ocular hypertension | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01655758 Comparator | Jan 2002 → Dec 2003 | ocular hypertension | University of Parma | Completed | No outcome recorded |
| — | NCT05241938 Comparator | Sep 2021 → Dec 2022 | ocular hypertension, open-angle glaucoma | Federal University of Rio Grande do Sul | Unknown | No outcome recorded |
| — | NCT02774811 Comparator | Feb 2014 → Jan 2019 | glaucoma | University College, London | Terminated | No outcome recorded |
| — | NCT01068964 Comparator | Feb → Sep 2010 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
| — | NCT00773136 Comparator | Feb → Jul 2008 | hypertrichosis | University of Miami | Completed | No outcome recorded |
| — | NCT00567788 Comparator | Jul 2006 → Jul 2008 | chronic closed-angle glaucoma | Singapore National Eye Centre | Unknown | No outcome recorded |
| — | NCT00187577 Comparator | Jun 2005 → Feb 2006 | alopecia areata | University of California, San Francisco | Completed | No outcome recorded |
| — | NCT05338606 Background | — | open-angle glaucoma | AbbVie | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-03-09 | SpyGlass Pharma, Inc. | Results SpyGlass Pharma Announces Positive Topline 12-Month Phase 1/2 Trial Results for Its Innovative BIM-IOL System spyglasspharma.com ↗
98% of evaluable patients (48 of 49) in the 78-mcg dose group and 96% of evaluable patients (22 of 23) in the 39-mcg dose group were free from all topical IOP-lowering medications. |
| 2025-09-23 | Impax Laboratories, LLC | Regulatory Amneal Receives U.S. FDA Approval for Bimatoprost Ophthalmic Solution, 0.01% amneal.com ↗
Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01% (2.5 mL, 5 mL and 7.5 mL). |
| 2023-12-14 | NicOx Inc. | Results Nicox’s Announces Publication of New Nonclinical Data Demonstrating More Effective Intraocular Pressure Lowering of NCX 470 compared to Lumigan nicox.com ↗
The publication “ NCX 470 Reduces Intraocular Pressure More Effectively Than Lumigan in Dogs and Enhances Conventional and Uveoscleral Outflow in Non -Human Primates and Human Trabecular Meshwork/Schlemm’s Canal Constructs” by Galli et al. is available by clicking here. |
| 2023-07-26 | Impax Laboratories, LLC | Regulatory Amneal Submits Abbreviated New Drug Applications to U.S. FDA for Three Key Complex Generics amneal.com ↗
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has submitted Abbreviated New Drug Applications (“ANDA”) to the U.S. Food and Drug Administration (FDA) for three key complex generic products, including: |
| 2019-04-01 | Alembic Pharmaceuticals Ltd. | Regulatory 15th April, 2019, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bimatoprost Ophthalmic Solution, 0.03%. |
| 2015-02-23 | Lupin Limited | Regulatory Lupin Receives US FDA Approval for Generic Lumigan® Ophthalmic Solution 0.03%. lupin.com ↗ |
All press releases naming this drug 13 releases
Evidence & citations 26 cited values
Every value below carries the sentence it was read from. 143 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bimatoprost | “a topical prostaglandin analogue eye drop. (latanoprost 0.005% 1 gtts in study eye qhs OR travoprost 0.004% 1 gtts in study eye qhs OR bimatoprost 0.01% 1 gtts in study eye qhs...” NCT01535768 ↗137“prostaglandin analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one - randomised eye.” NCT01927406 ↗ “Fixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution)” NCT01168414 ↗ “GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.” NCT03284853 ↗ “Prostaglandin analogue eye drops (latanoprost, bimatoprost or travoprost) will be prescribed” NCT05241938 ↗ “Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.” NCT02017327 ↗ “Compare also to timolol/brimonidine/dorzolamide/bimatoprost” NCT06369077 ↗ “Group 4 extended-wear contact lens printed with bimatoprost” NCT04747808 ↗ “Lumigan ® 0.01% (Bimatoprost Ophthalmic Solution)” NCT03927443 ↗ “LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%)” NCT02419508 ↗ “Latanoprost Travaprost Bimatoprost Tafluprost” NCT03292796 ↗ |
| Known as | "Lumigan" is the branded name of bimatoprost in eye drop form | “"Lumigan" is the branded name of bimatoprost in eye drop form” NCT02537015 ↗1“"Lumigan" is the branded name of bimatoprost in eye drop form” NCT02143843 ↗ |
| Known as | AGN 192024 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200963 ↗ |
| Known as | BIM | “BAK-free travoprost 0.004% (TRAV) and BAK 0.02%-preserved bimatoprost 0.01% (BIM) during late-day time points in patients with open-angle glaucoma or ocular hypertension.” PMID 25432143 ↗ Nov 2014 |
| Known as | Bimatoprost 0.03% solution (Lumigan) | “Bimatoprost 0.03% solution (Lumigan)” NCT00187577 ↗ |
| Known as | Bimatoprost component of ganfort | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200963 ↗ |
| Known as | Bimatoprost Implant System | “Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL” NCT06120842 ↗ |
| Known as | Bimatoprost SR | “Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration.” NCT02507687 ↗1“received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study” NCT03891446 ↗ |
| Known as | bimatoprost sustained-release (SR) | “This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension.” NCT02250651 ↗ |
| Known as | BUDPF | “After the follow-up visit, patient will start Preservative-free bimatoprost 0.03% Unit Dose (BUDPF) eye drops every day at 21:00 for the last 3 months.” NCT01975714 ↗ |
| Known as | Durysta | “Participants in this arm will receive a one-time injection of Durysta (intracameral bimatoprost 10mcg).” NCT07217678 ↗1“Durysta, Bimatoprost Intracameral Implant 10 µg” NCT05335122 ↗ |
| Known as | DurystaTM | “Currently, Bimatoprost SR (DurystaTM) from Allergan plc is the only FDA-approved SR therapy for POAG.” PMID 35076329 ↗ Dec 2022 |
| Known as | Latisse | “Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™).” NCT02170662 ↗ |
| Known as | Lumigan | “Bimatoprost ophthalmic solution 0.01% (LUMIGAN®) administered once daily in the evening 5 minutes after COMBIGAN® instillation if additional lowering IOP is needed” NCT02863705 ↗9“Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™).” NCT02170662 ↗ “dosed with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled in each eye once daily for 28 days” NCT01937312 ↗ “bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.” NCT01110499 ↗ “Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year” NCT00705757 ↗ “Bimatoprost, aka Lumigan, one drop in one eye nightly” NCT03708627 ↗ “Bimatoprost (Lumigan) ophthalmic solution” NCT00187577 ↗ “bimatoprost = Lumigan®” NCT00541242 ↗ |
| Known as | LUMIGAN (Bimatoprost ophthalmic solution, 0.01%) | “LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%)” NCT02419508 ↗ |
| Known as | Lumigan 0.01% | “Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.” NCT02017327 ↗ |
| Known as | Lumigan 0.03% Unit Dose | “Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.” NCT02017327 ↗ |
| Known as | LUMIGAN RC | “Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.” NCT01833741 ↗ |
| Known as | Lumigan TM | “Three of these are commonly used in North America: latanoprost (Latanoprost T, Pfizer), Travoprost (Travatan TM, Alcon) and bimatoprost (Lumigan TM, Allergan).” NCT01361841 ↗ |
| Known as | Prostamide | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200963 ↗ |
| Known as | T4032 | “Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients” NCT05397600 ↗1“Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers” NCT05729594 ↗ |
| Known as | ZOLYMBUS | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07845357 ↗ |
| Action | Activate | “Prostanoid FP receptor agonist” CHEMBL1200963 ↗ |
| Modality | Other / unclassified | “prostaglandin analogues bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004% (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®)” NCT01253902 ↗ |
| Route | Topical | “Bimatoprost solution will be applied to affected eyelid(s) with cotton-tipped applicator daily.” NCT00187577 ↗ |
| Target | PTGFR | “Prostanoid FP receptor agonist” CHEMBL1200963 ↗ |